According to the American Diabetes Association, over 23.6 million children and adults within the United States alone (7.8% of the population) have diabetes. About 1 in every 400 to 600 children and adolescents has type 1 diabetes, requiring daily injections of insulin to regulate his/her blood sugar. In adults, type 1 diabetes accounts for 5-10% of all diagnosed cases of diabetes. To manage the injection of insulin on a daily basis, different technologies have emerged to regulate insulin delivery. However, insulin must be regulated on an individual basis. Thus, a dose correct for an adult could be life threatening to a child. Accordingly, regardless of the different technologies in place to regulate insulin, insulin remains one of the top high alert drugs on the Institute for Safe Medication Practices' (ISMP's) list of High-alert Medications.
Insulin is dispensed in units that correspond to an individual's body mass, age, and blood sugar levels. Current injection pens and cartridges accommodate multiple doses so that an individual can dispense the proper amount of insulin and can typically use each pen or cartridge multiple times before it is empty. However, it is becoming increasingly difficult to use these unit doses of insulin to effectively treat diabetic patients in view of growing population trends.
In October 2003, the Centers for Disease Control and Prevention (CDC) reported that the average BMI (i.e., body mass index, which is a weight-for height formula used to measure obesity) has increased among adults from approximately 25 in 1960 to 28 in 2002. Meanwhile, the average weight for men aged 20-74 years rose dramatically from 166.3 pounds in 1960 to 191 pounds in 2002, while the average weight for women the same age also increased dramatically from 140.2 pounds in 1960 to 164.3 pounds in 2002. Insulin manufacturers have responded by creating higher doses of insulin in an effort to accommodate people who require large doses. The American Society of Health-System Pharmacists (ASHP) published an article about the use of concentrated insulin human regular (U-500) and the concerns associated with dispensing at these high doses. This article recommended that the health care professionals be well educated and vigilant about patient safety issues regarding the drug's prescription, dosing, and administration. (Segal, A. R. et al., “Use of Concentrated Insulin Human Regular (U-500) for Patients with Diabetes,” American Journal of Health-System Pharmacists, Sep. 15, 2010, 67:1526-1535).
A need therefore exists for a drug delivery device that can help address concerns about high dose insulin and other high alert drugs by ensuring that the drug will be delivered at the correct dose into the patient.
Additionally, insulin and other drugs contained in injection pens are subject to degradation over time. Insulin should be kept refrigerated before use and expires within days once the insulin is in use. Having insulin cartridges that monitor the temperature and/or degradation of the insulin could prevent medication errors that occur due to improper handling, temperature exposure, light exposure or time elapse.
A need therefore also exists for a drug delivery device (e.g., an insulin pump or injection pen needle) that has the capability of accurately verifying a drug before being administered, and/or catching medication errors due to drug expiration, degradation, contamination, and so on.
Also, a need exists for a drug delivery device that has the capability of transferring comprehensive documentation, patient information, and scientific fluid identification, all in one device.